Insufflation Tubing & Filter

FDA 510(k) K941094 · H & C Chemical, Inc.

Substantially Equivalent

510(k) numberK941094

Submission

Device name
Insufflation Tubing & Filter
Applicant
H & C Chemical, Inc.
Minneapolis, MN, US
Received
March 8, 1994
Decision date
May 10, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HET – Laparoscope, Gynecologic (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 884.1720
Specialty
Obstetrics/Gynecology

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Questions and answers

When was Insufflation Tubing & Filter cleared by the FDA?

Insufflation Tubing & Filter (K941094) received a 510(k) decision of Substantially Equivalent on May 10, 1994, 63 days after the submission was received.

What is the product code of K941094?

The FDA product code is HET – Laparoscope, Gynecologic (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 884.1720.